At a Glance
- Tasks: Lead global regulatory strategies for innovative pharmaceutical products and ensure compliance.
- Company: Join a leading pharmaceutical company with a focus on innovation and collaboration.
- Benefits: Hybrid work model, competitive pay, and opportunities for professional growth.
- Other info: Dynamic team environment with potential for career advancement.
- Why this job: Make a real impact in the pharmaceutical industry while working on exciting projects.
- Qualifications: Degree in life sciences and experience in regulatory submissions required.
The predicted salary is between 63000 - 77000 £ per year.
- Type of Role
- Contract position, Inside IR35
- Location
Hybrid, 3 days on site in Paddington, London.
- Department
- Regulatory – Chemistry Manufacturing Controls
- General Summary
The Manager, Regulatory Chemistry Manufacturing Controls will influence the execution of multi-product global regulatory CMC strategies for investigational and marketed products.
This role contributes to the preparation and submission of regulatory CMC documentation and with interactions with Health Authorities for CMC topics.
This role also provides regulatory support and guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial programs.
- Key Duties and Responsibilities
- Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies.
- Contributes to the development of global regulatory CMC strategies for investigational and/or commercial products.
- Works with regulatory colleagues in development of global regulatory CMC strategies and submissions.
- Provides regulatory CMC guidance to cross-functional teams and key stakeholders.
- Influences regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.
- Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects.
- Knowledge and Skills
- Strong interpersonal skills to exchange complex information with others and to guide others.
- Proficiency in regulatory (SFDA, EMA, Health Canada and ICH) guidelines.
- Experience in the preparation, including writing, of CMC submissions.
- Strategic thinking and strong problem-solving skills.
- Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner.
- Strong sense of planning and prioritization, and the ability to work with all levels of management.
- Capable of strategic thinking with ability to resolve complex and ambiguous situations.
- Sound knowledge of c GMP, FDA, EMA, ICH.
Education and Experience
- Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
- Experience in the pharmaceutical industry or related field, or the equivalent combination of education and experience.
Vertex is partnering with Talent Works to manage their international temporary job openings.
If you are successful in your application, you will be employed by Talent Works to work on a temporary assignment at Vertex.
- Seniority Level
- Mid-Senior level
- Employment Type
- Contract
- Job Function
- Other
- Industries
- Pharmaceutical Manufacturing
- #J-18808-Ljbffr
Manager, Regulatory CMC employer: Vertex Pharmaceuticals
Vertex Pharmaceuticals is an exceptional employer that prioritises employee well-being and professional growth. With a flexible hybrid working model, our team enjoys a supportive work culture that fosters collaboration and innovation, while also providing ample opportunities for career advancement in the dynamic field of tax compliance.
StudySmarter Expert Advice🤫
We think this is how you could land Manager, Regulatory CMC
✨Unlock Networking Opportunities
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Vertex Pharmaceuticals.
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If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Vertex Pharmaceuticals. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
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When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Vertex Pharmaceuticals is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Manager, Regulatory CMC
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Vertex Pharmaceuticals!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Vertex Pharmaceuticals that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Vertex Pharmaceuticals!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Vertex Pharmaceuticals, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Vertex Pharmaceuticals
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Vertex Pharmaceuticals that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Vertex Pharmaceuticals’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
